Lamivudine 100mg Tablets

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

LAMIVUDINE-HBV - ORAL

(la-MIV-ue-deen)

COMMON BRAND NAME(S): Epivir HBV

WARNING: Lactic acid buildup in the blood (lactic acidosis) and sometimes fatal liver disease have occurred with the use of lamivudine-HBV, used both alone and in combination with other drugs for treating human immunodeficiency virus (HIV) infection. HIV counseling and testing should be offered to all patients both before and during treatment with lamivudine-HBV. Lamivudine-HBV contains a lower dose of the drug lamivudine, which is used to treat HIV infection as well as hepatitis B. Use of lamivudine-HBV in patients with unknown or untreated HIV infection could result in new types of HIV virus that are more difficult to treat (drug-resistant). Severe worsening of hepatitis has occurred when this medication is stopped. Liver and blood testing should continue for several months after lamivudine-HBV is stopped. Consult your doctor or pharmacist for more information.

USES: Lamivudine-HBV is used to treat hepatitis B infection. It is not a cure for hepatitis B and does not prevent the passing of hepatitis B to others. This medication is a nucleoside reverse transcriptase inhibitor (NRTI) that works by slowing the growth of the virus, thereby decreasing liver damage caused by the virus.

HOW TO USE: Read the Patient Information Leaflet provided by your pharmacist before you start using lamivudine-HBV and each time you get a refill. If you have any questions regarding the information, consult your doctor or pharmacist. Take lamivudine-HBV by mouth with or without food, usually once a day or as directed by your doctor. Use this medicine regularly in order to get the most benefit from it. This medication works best when the amount of drug in your body is kept at a constant level. Remember to use it at the same time each day. Do not skip any doses. Dosage is based on your medical condition and response to therapy. Do not stop taking this medication without consulting your doctor. Worsening of your condition, decreased response to medication, or development of drug-resistant types of the virus may occur during or after treatment. Promptly report any new symptoms that occur during or after treatment to your doctor.

SIDE EFFECTS: Nausea, vomiting, diarrhea, dizziness, headache, fatigue, or infections of the ear/nose/throat may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor right away if any of these unlikely but serious side effects occur: mental/mood changes, muscle/joint pain, persistent nausea/vomiting, stomach/abdominal pain, dark urine, yellowing of eyes/skin. Tell your doctor right away if any of these rare but very serious side effects occur: deep/rapid breathing, drowsiness, tingling/numbness in hands or feet. A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking lamivudine-HBV, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: pancreatitis. Before using lamivudine-HBV, tell your doctor or pharmacist your medical history, especially of: HIV infection, kidney disease, blood disorders, liver disease. This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages. Liquid preparations of lamivudine-HBV contain sugar (sucrose). If you are a diabetic using the liquid form of this drug, closer monitoring of your blood sugar is recommended as you begin using this drug. Talk with your doctor or pharmacist for more details. Kidney function declines as you grow older. This medication is removed by the kidneys. Therefore, elderly people may be at a greater risk for side effects while using this drug. Children, especially those with pancreatitis, may be more sensitive to the effects of this drug. This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor. This medication has not been shown to prevent the passing of hepatitis B from the mother to the newborn. Consult your doctor for more information. This medication may pass into breast milk and have undesirable effects on a nursing infant. Therefore, breast-feeding is not recommended while using this drug. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor\'s approval. Do not take this medication with other products (including those that treat HIV infection) that contain lamivudine. Emtricitabine is similar to lamivudine and should not be taken with this medication. Lamivudine-HBV can affect the results of certain lab tests (e.g., liver function tests). Make sure laboratory personnel and your doctors know you use this drug.

OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES: To avoid spreading hepatitis B to others, always use an effective barrier method (e.g., latex condoms/dental dams) during sexual activity. Consult your doctor or pharmacist for more details. Do not share this medication with others. Laboratory and/or medical tests (e.g., liver function tests, blood chemistries, complete blood counts, hepatitis B virus DNA levels) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details. Different brands of this drug have different amounts of active drug. Do not switch brands of this medication without first checking with your doctor. If you have an HIV infection, you should be taking the higher-strength dosage. Consult your doctor or pharmacist for more details.

MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: US products: Store the tablets at room temperature at 77 degrees F (25 degrees C) away from light and moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Store the oral solution at room temperature between 68-77 degrees F (20-25 degrees C) in a tightly closed bottle. Canadian products: Store the tablets between 35.6 and 86 degrees F (2 and 30 degrees C) away from light and moisture. Store the oral solution at room temperature between 59 and 77 degrees F (15 and 25 degrees C) in a tightly closed bottle. Do not store in the bathroom. Keep all medicines away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised July 2016. Copyright(c) 2016 First Databank, Inc.